Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardioverter Defibrillators

Hazard

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

Details from the source

Reason for recall: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds. Distribution: US Nationwide - Worldwide Distribution Quantity: 435 units Lot/code info: GTIN 00643169720299, Lot Serial Numbers; BLR602282S, BLR602271S, BLR602274S, BLR602363S, BLR602366S, BLR602278S, BLR602289S, BLR602365S, BLR602238S, BLR602293S, BLR602325S, BLR602332S, BLR602333S, BLR602334S, BLR602336S, BLR602337S, BLR602340S, BLR602353S, BLR602360S, BLR602361S, BLR602356S, BLR602236S, BLR602237S, BLR602290S, BLR602296S, BLR602306S, BLR602338S, BLR602341S, BLR602358S, BLR602378S, BLR602335S, BLR602339S, BLR602359S, BLR602308S, BLR602328S, BLR602330S, BLR602331S, BLR602352S, BLR602357S, BLR602390S, BLR602269S, BLR602381S, BLR602382S, BLR602383S, BLR602384S, BLR602387S, BLR602398S, BLR602394S, BLR602395S, BLR602385S, BLR602386S, BLR602388S, BLR602397S, BLR602379S, BLR602380S, BLR602389S, BLR602362S, BLR602377S; GTIN 00643169980112, Lot Serial Numbers: BLR602821S, BLR602777S, BLR602490S, BLR602342S, BLR602492S, BLR602425S, BLR602408S, BLR602430S, BLR602515S, BLR602516S, BLR602518S, BLR602520S, BLR602530S, BLR602531S, BLR602534S, BLR602535S, BLR602537S, BLR602540S, BLR602542S, BLR602544S, BLR602545S, BLR602546S, BLR602548S, BLR602550S, BLR602552S, BLR602554S, BLR602555S, BLR602587S, BLR602632S, BLR602633S, BLR602638S, BLR602639S, BLR602640S, BLR602644S, BLR602645S, BLR602647S, BLR602669S, BLR602670S, BLR602672S, BLR602682S, BLR602710S, BLR602711S, BLR602751S, BLR602752S, BLR602753S, BLR602754S, BLR602760S, BLR602763S, BLR602770S, BLR602773S, BLR602787S, BLR602788S, BLR602789S, BLR602790S, BLR602791S, BLR602792S, BLR602793S, BLR602794S, BLR602795S, BLR602796S, BL

UPC codes

00643169720299, 00643169980112, 00763000612283

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.